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Biomarker based clinical trial design

	author = {Richard Simon},
	title = {Biomarker based clinical trial design},
	journal = {Chinese Clinical Oncology},
	volume = {3},
	number = {3},
	year = {2014},
	keywords = {},
	abstract = {The established molecular heterogeneity of human cancers and the subsequent stratification of conventional diagnostic categories require the development of new paradigms for the development of a reliable basis for predictive medicine. We review clinical trial designs for the development of new therapeutics and predictive biomarkers to inform their use. We cover designs for a wide range of settings. At one extreme is the development of a new drug with a single biomarker and strong biological evidence that marker negative patients are unlikely to benefit from the new drug. At the other extreme are phase III clinical trials involving both genome-wide discovery and internal validation of a predictive classifier that identifies the patients most likely and unlikely to benefit from the new drug.},
	issn = {2304-3873},	url = {}